Azithromycin for Patients With Chronic Rhinosinusitis Failing Medical and Surgical Therapy
Information source: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Rhinosinusitis; High-risk Patient
Intervention: Azithromycin (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Centre hospitalier de l'Université de Montréal (CHUM) Official(s) and/or principal investigator(s): Martin Y Desrosiers, MD, FRCSC, Principal Investigator, Affiliation: CHUM
Overall contact: Leandra Mfuna Endam, MSc, Phone: 5148908000, Ext: 14170, Email: leandra.mfuna-endam.chum@ssss.gouv.qc.ca
Summary
Justification: Chronic rhinosinusitis (CRS) is one of the most common inflammatory diseases
with an incidence and prevalence superior to 10%. Unfortunately, more than 30% of patients
do not respond to standard medical and surgical treatment, thus continuously increasing the
symptomatologic and socio-economic burden of this disease.
Hypothesis: The investigators believe that the addition of azithromycin (AZI) to the
treatment regimen of patients with refractory CRS failing conventional medico-surgical
treatment will be beneficial in a symptomatologic and endoscopic level.
Primary objective: 1- To evaluate whether Azithromycine 250 mg PO three times weekly is
effective in controlling signs and symptoms of CRS in high-risk patients unresponsive to
standard management after endoscopic sinus surgery (ESS) with budesonide irrigations.
Secondary objectives:
i) Validate a simple and concise treatment algorithm for patients refractory to standard CRS
treatment of ESS and BUDI, with the addition of low-dose AZI.
ii) Characterise and define the population deemed "high-risk" for standard CRS treatment
failure by evaluating: 1) demographics, 2) inflammatory states and 3) the nasal flora
microbiome of patients at the different follow-up points of this study.
iii) Explore the mechanisms of AZI by assessing the changes in inflammatory states and the
nasal flora microbiome associated with successful AZI therapy.
Methods: Inclusion of all patients admitted for endoscopic sinus surgery (ESS) for CRS
operated by the same surgeon (MD). Following their first postoperative visit (2 weeks), all
patients will receive nasal irrigations with budesonide (BUDI) twice daily for 4 months and
will be re-evaluated. If there is a failure of treatment, patients eligible to receive AZI
will be randomized in to two groups, AZI 250mg or a placebo three times a week for 4 months.
At every follow-up, complete endoscopic exams will be performed, along with sinus cultures
and brush cytology.
Population: All patients deemed "high-risk" with CRS admitted for ESS between October 2014
and October 2015.
Clinical Details
Official title: Azithromycin as add-on Therapy in Patients Failing Medical and Surgical Treatment for Chronic Rhinosinusitis: a Double-blind, Randomized, Placebo-controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Signs and symptoms outcome to Azithromycin
Secondary outcome: Treatment algorithm validationHigh-risk population Azithromycin mechanism of action
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Patients with ≥1 of the following criteria:
- history of sinus surgery,
- first sinus surgery at ≤38 years of age,
- an absolute eosinophilia of ≥500 cells/mm,
- serum IgE levels of >150 kIU/L,
- a Gram negative bacteria in a sinus culture,
- the presence of intra-operative eosinophilic mucin.
Exclusion Criteria:
- Patients with cystic fibrosis, inverted papillomas, osteomata, mucoceles or other
lesions of the base of skull will be excluded.
- Patients with an elevated cardiovascular disease risk will be excluded from the
randomized clinical trial part of this study.
Locations and Contacts
Leandra Mfuna Endam, MSc, Phone: 5148908000, Ext: 14170, Email: leandra.mfuna-endam.chum@ssss.gouv.qc.ca
Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, Quebec H2W 1T8, Canada; Recruiting Leandra Mfuna Endam, MSc, Phone: 514-890-8000, Ext: 14170, Email: leandra.mfuna-endam.chum@ssss.gouv.qc.ca Martin Desrosiers, MD, FRCSC, Phone: 514-890-8444, Email: desrosiers_martin@hotmail.com Martin Desrosiers, MD, FRCSC, Principal Investigator
Additional Information
Related publications: Maniakas A, Desrosiers M. Azithromycin add-on therapy in high-risk postendoscopic sinus surgery patients failing corticosteroid irrigations: A clinical practice audit. Am J Rhinol Allergy. 2014 Mar-Apr;28(2):151-5. doi: 10.2500/ajra.2013.27.4017. Epub 2013 Dec 13. Desrosiers MY, Kilty SJ. Treatment alternatives for chronic rhinosinusitis persisting after ESS: what to do when antibiotics, steroids and surgery fail. Rhinology. 2008 Mar;46(1):3-14. Review. Desrosiers M, Evans GA, Keith PK, Wright ED, Kaplan A, Bouchard J, Ciavarella A, Doyle PW, Javer AR, Leith ES, Mukherji A, Robert Schellenberg R, Small P, Witterick IJ. Canadian clinical practice guidelines for acute and chronic rhinosinusitis. J Otolaryngol Head Neck Surg. 2011 May;40 Suppl 2:S99-193. Review. English, French. Nader ME, Abou-Jaoude P, Cabaluna M, Desrosiers M. Using response to a standardized treatment to identify phenotypes for genetic studies of chronic rhinosinusitis. J Otolaryngol Head Neck Surg. 2010 Feb;39(1):69-75.
Starting date: November 2014
Last updated: December 3, 2014
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